Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Metamizole and Acetaminophen iv; Drug: Epidural analgesia:Levobupivacaine0,125%; Drug: Port-sites infiltration:Bupivacaine0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT02662660

HGUE 16-03

Details and patient eligibility

About

A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.

Full description

A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.

Enrollment: 147 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• body mass index (BMI) >40 Kg/m2
• BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion criteria

• patients undergoing other bariatric techniques
• severe underlying cardiovascular diseases
• chronic renal failure
• hepatic dysfunction
• previous foregut surgery
• patients with any contraindication for bariatric surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 3 patient groups

Port-sites infiltration:Bupivacaine0,25%

Experimental group

Description:

Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Treatment:

Drug: Port-sites infiltration:Bupivacaine0.25%

Drug: Metamizole and Acetaminophen iv

Epidural analgesia:Levobupivacaine0.125%

Experimental group

Description:

Epidural analgesia consists in the placement of a thoracic epidural catheter inserted at the level T6-T7 and administration of a continuous perfusion of Levobupivacaine 0.125% 6ml/h. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Treatment:

Drug: Metamizole and Acetaminophen iv

Drug: Epidural analgesia:Levobupivacaine0,125%

Metamizole and Acetaminophen iv

Active Comparator group

Description:

Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Treatment:

Drug: Metamizole and Acetaminophen iv